- Johnson & Johnson has agreed to pay $120 million in a 46-state settlement announced Tuesday regarding misrepresentation of the effectiveness, longevity and safety of two hip replacement products marketed by J&J artificial joint subsidiary DePuy Orthopaedics following FDA authorizations in the early 2000s.
- The investigation, led by the South Carolina and Texas attorneys general offices, addressed the ASR XL device, which DePuy recalled in 2010, and the Pinnacle Ultamet implant, which the company discontinued in 2013. Both implants were found to have violated consumer protection laws by having faster deterioration rates, or shorter "survivorship," than advertised, limiting device value for patients and leading to a variety of health complaints.
- The settlement also involved a commitment from DePuy to revise how it promotes and tracks its current extensive line of hip replacement products, which collectively brought in $1.4 billion in revenue for J&J in 2018. Provisions of the consent judgment include basing any future marketing on the most recent scientific information available, maintaining a postmarket surveillance program and conducting quarterly reviews of customer complaints.
The case hinged primarily on Johnson & Johnson's claims at time of marketing that the ASR XL device had a survivorship rate of 99.2% after three years, and for Pinnacle Ultamet, a rate of nearly 99.9% at five years, when the National Joint Registry of England and Wales found revision rates for those spans to be 7% and nearly 4.3%, respectively. The attorneys general also reported that patients with the defective devices or required surgery to replace the implants experienced symptoms like groin pain, allergic reactions, tissue necrosis and build-up of metal ions in the blood.
Companies should never be allowed to freely mislead the public, especially when there are health concerns involved.— NY AG James (@NewYorkStateAG) January 22, 2019
This serves as an important message that deceptive and false medical practices will never be tolerated.
The $120 million settlement represents a small fraction of J&J's worldwide legal troubles related to the metal-on-metal hip implants, which have been a rallying point for device safety advocates. The implants were a primary subject of a worldwide medical implant review by the International Consortium of Investigative Journalists in 2018. Renewed discussion of device scrutiny from FDA coincided with rollout of the reports.
DePuy reached agreements in November 2013, February 2015 and March 2017 to settle more than 10,000 claims from U.S. plaintiffs who had revision surgery to replace their ASR hips, according to a late 2018 quarterly report from J&J. Class action litigation surrounding similar hip implant issues has been filed in numerous countries outside the U.S., including the United Kingdom, Canada, Australia, Ireland, Germany and Italy. The company acknowledged that recent settlements do not mark an end to the ASR and Pinnacle cases in saying that complaints continue to be brought forward and some lawsuits have yet to be resolved.
Diana Zuckerman, president of the National Center for Health Research, called the settlement "a very small price to pay" for a company like J&J, in a statement to MedTech Dive. "Paying $120 million is not going to persuade any large device company to be more honest in their marketing in the future," she said.
Zuckerman also noted that the burden of flawed devices extends to taxpayers and health insurance customers. "We all have contributed to paying the costs of replacing metal-on-metal hip implants and the cost of additional medical care for patients harmed by them," she said.
The announcement came the same day Johnson & Johnson reported fourth quarter and 12-month earnings for 2018, which included worldwide yearly hip sales of $1.4 billion. Overall fourth quarter litigation expenses for J&J approached $1.29 billion, practically double the amount from a year earlier. J&J stock was down slightly at market close Tuesday.